I hope Outsourced Pharma readers will enjoy this editorial with Civica Rx President & CEO Martin VanTrieste, featured in this month’s issue of Life Science Leader magazine. VanTrieste has a business plan that could set the generics industry on a new path of full disclosure of drug-manufacture origin, and direct delivery to the point of patient use. Part 2 of this feature will be released next month, with a direct focus on CDMOs and Civica.
The CDMO industry has benefitted from big pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The sector has grown at a consistent 7 percent compound annual growth rate (CAGR) for the better part of a decade, outpacing that of the greater pharmaceutical industry itself. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.
Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives.
Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.
Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
Biopharmaceutical manufacturer’s goals are to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial manufacturing. Traditionally, column packing has been considered a bottleneck. Suboptimal packing is not only time-consuming, but can result in poor performance. By eliminating these two concerns, you can focus on the core process.
Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
Along with proficient monitoring and tracking resources, Fisher Clinical Services optimizes every level of the cold chain process to ensure the security of clinical trial supplies.
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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.
Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.
